Vivani (Formerly Second Sight) Files IPO Prospectus: Pioneering the Future of Bioelectronic Medicine and Implantable Drug Delivery

In 1933, American author Helen Keller wrote *Three Days to See*, expressing her longing for sight and her love for the world. Eighty years later, a U.S. companySecond SightTurning this fantasy into reality.

In 2013, Second Sight’s Argus II bionic eye, developed on the basis of bioelectronic materials, received approval from the U.S. Food and Drug Administration.This device converts light entering the eye into electronic signals, bypassing diseased and necrotic tissue to transmit them directly to the optic nerve. Although it only produces outlines of objects and dim light perception, this is sufficient for many blind individuals.

This product propelled Second Sight to immense popularity, establishing it as the recognized global leader in neuromodulation devices for blindness. However, seven years later, the company faced rumors of auctioning off its physical assets and teetering on the brink of bankruptcy.In 2022, Second Sight announced its merger with the biopharmaceutical company Nano Precision Medical and was renamed Vivani, focusing primarily on the development of pharmaceuticals and medical device implants.From the outcome, Second Sight appears to have “reinvented itself.”

The story of Second Sight begins with a routine ophthalmic surgery.

In 1991, Robert Greenberg, who had just become a medical student, was observing an ophthalmic surgery. The surgeon inserted a thin wire into the eye of a visually impaired patient. A mild electrical current generated stimulation, and the patient immediately responded, “There’s a bright spot!” When a second wire was inserted, the two points in the patient’s previously dark visual field became two distinct spots.

Before becoming a medical student, Robert Greenberg was an electrical engineer with extensive experience in electronic materials. He keenly observed, “If enough points of light could be generated through wires, could visually impaired patients regain their sight?”

Inspired by this, Robert Greenberg decided to develop a device that could restore vision to patients with eye diseases. Initially,Possessing dual expertise in medicine and electrical engineeringRobert Greenberg was supremely confident, believing that the goal could be achieved simply by designing an electrode stimulator. However, upon launching the project, it became clear that this was no easy task; the stimulation sites, number of electrodes, and intensity levels all required extensive iterative research.

As biology and electronics converge, bioelectronic materials become particularly important.Bioelectronic materials serve as the foundation for implants, requiring not only excellent biocompatibility to prevent adverse patient reactions but also the ability to transmit signals to achieve therapeutic functions.

In 1996, to turn fantasy into reality, Robert Greenberg decided to recruit a broad range of partners and establish Second Sight. Together, they addressed critical technical challenges, such as matching electrode devices with thin, precision retinal implants and ensuring the implants functioned in saline solution. Ultimately, they developed the first bionic eye in 2002.Argus IThis bionic eye features 16 electrodes to stimulate the retina, and the surgical procedure requires four surgeons working for eight hours to complete. Although it ultimately passed clinical trials, Argus I was not commercialized due to internal considerations.

Five years later, Second Sigh launched its second-generation productArgus Ⅱ. Notably, compared with the first-generation product, this bionic eye features 60 electrodes and was the smallest neural stimulator in the world at the time; meanwhile, implantation is more convenient, requiring only a single surgeon to complete the procedure within three hours.

The Argus II consists of three components: a retinal implant, a signal-capturing camera, and a video processing unit. The signal-capturing camera is mounted on specially designed sunglasses to collect data from the patient’s visual field. The video processing unit, comparable in size to a mobile phone, can be worn on the patient’s waist.

Upon receiving data from the camera, the signal processor converts it into a pattern of 60 black-and-white pixels and transmits it back to the sunglasses, which then wirelessly relay the information to the retinal implant. The implant’s 60 electrodes stimulate the optic nerve in a specific manner, generating phosphenes corresponding to the low-resolution video signal, thereby enabling the patient to “see” images.

In 2011, Argus II received approval from the EMA, and in 2013, it officially obtained FDA approval, marking the peak of its commercialization.According to Robert Greenberg’s later recollections, Second Sight submitted a PMA application for the Argus II comprising as many as 10,000 pages before finally obtaining approval.

With the Argus II, Second Sight surged to the forefront of the bionic eye sector, with its influence even extending into the field of bioelectronic materials. However, rapid expansion also led to significant internal conflicts within the company.

In 2019, Second Sight internally recognized that the profit margins for Argus II were limited and publicly announced its plan to phase out retinal implant technology to lay the groundwork for developing Orion, its next-generation brain implant technology. Meanwhile, founder Robert Greenberg had significant disagreements with the company’s board of directors and ultimately left Second Sight.

Poor decision-making led to continuous losses at Second Sigh, resulting in large-scale layoffs that saw the CEO, senior R&D engineers, and a significant number of employees depart the company.Amid a declining market economy and shrinking market space, Second Sigh faced deficits, with large volumes of physical assets auctioned off; rumors of bankruptcy even circulated in 2020.Rumors may be a mix of truth and fiction, but one thing is certain: the former giant of bioelectronic materials has lost its former glory.

However, with the advancement of medical technology, beyond merely collecting and releasing various physiological signals, greater potential of bioelectronic materials is being uncovered, including the development of drug delivery systems, human–machine interface monitoring, and the treatment of conditions such as skin wounds, diabetes, ocular diseases, cancer, and cardiovascular and neurological disorders.

Among these, the role of bioelectronic materials in drug delivery is gaining increasing attention. In recent years, with successive breakthroughs in drug research and development, researchers have begun to explore safer, more effective, and lower-side-effect delivery methods.

Bioelectronic materials with specific molecular recognition capabilities not only facilitate early diagnosis and targeted therapy of drugs but also help drugs better penetrate cell membranes. They possess functions such as improving drug properties and enabling targeted drug delivery, thereby enhancing drug efficacy and reducing side effects, which promotes the development of personalized medicine.

Against this backdrop, Second Sight has finally turned a corner.In 2022, Second Sight Medical announced its merger with the biopharmaceutical company Nano Precision Medical, forming a new entity named Vivani., the company will develop drugs and medical device implants under the leadership of Adam Mendelsohn, former CEO of Nano Precision Medical.

It is reported that Nano Precision Medical has developed a small subcutaneous drug implant capable of delivering various medications for chronic diseases at a long-term, nearly constant rate. The addition of Second Sight will not only enhance the device’s performance but also integrate Nano Precision Medical’s R&D team, thereby increasing its focus on drug molecule development and improving therapeutic efficacy.

Under this collaboration, Second Sight has also retained its core R&D team and secured funding to continue the development of bioelectronic materials.

It has proven that this partnership was a strategic success. Two years after its establishment, Vivani’s NPM-115 (high-dose exenatide implant) and NPM-139 (semaglutide implant) have entered clinical development, with LIBERATE-1 having received IND clearance from the FDA. Meanwhile, multiple drug pipelines focused on chronic diabetes management and weight management are also advancing.

Additionally, Orion, a neural stimulation system derived from Second Sight, has officially commenced research. Notably, the scope of application for Orion is no longer limited to visual impairment; it can also assist some paralyzed patients in recovering arm and hand function.

From a financial perspective, Vivani also has sufficient funds to support the progress of its research. As of March 31, 2024, Vivani’s total cash, cash equivalents, and restricted cash amounted to $31 million, which will support the company’s operations into the second half of 2025 and potentially enable the achievement of key product milestones.

A partnership could save Second Sight from the brink of bankruptcy, with the key factor being that bioelectronic materials have entered a period of rapid development.

Taking Second Sight’s core business—bionic eyes—as an example, numerous companies both in China and abroad have entered this field in its wake.For instance, the Australian company Monash Vision Group has developed the cortical visual device Gennaris, which has entered human clinical trials. Meanwhile, a team at the Hong Kong University of Science and Technology has developed the world’s first 3D artificial eye, EC-EYE. This device employs various micro-sensors to create images and is capable of detecting countless photoreceptor cells. The bionic eye’s interior cavity is filled with ionic liquid, and its thin, flexible wires, made of liquid metal, function similarly to nerve fibers.

These devices not only represent the cutting-edge advancements in bionic eye technology but also symbolize that bioelectronic materials have entered a new phase. Domestic research is currently gaining momentum. In recent years, Chinese scientific research teams have achieved a series of breakthroughs in this field:A research team led by Professor Zhang Lei at Zhejiang University has developed intrinsically conductive polymer materials; a team led by Liu Ji at Southern University of Science and Technology has developed novel hydrogel adhesives for bioelectronic interfaces, among other innovations.

Bioelectronic materials, as an emerging discipline, are garnering attention from research teams worldwide, holding significant importance for advancements in drug delivery, tissue engineering, and personalized medicine. Although domestic enterprises in China are still in the early stages of market development, the proliferation of scientific achievements indicates that the country possesses substantial untapped potential in this field. With the accelerated pace of industrialization, China is poised to achieve leapfrog development in the future, injecting new vitality into the biomedical sector.